FDA Grants EUA to Novavax COVID-19 Vaccine

On July 13, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Novavax’s COVID-19 vaccine. The FDA’s authorization of this vaccine provides an additional option for individuals who wish to get vaccinated against COVID-19. The Novavax vaccine is administered as a two-part primary vaccination series, with the two doses being administered three weeks apart. This vaccine is only available for the primary vaccination series; a booster dose is not yet available. The Novavax vaccine is available to adults 18 years of age and older.

In granting the Emergency Use Authorization, the FDA relied upon results from a clinical trial that included over 25,000 participants. In this clinical trial, the Novavax vaccine was shown to be 90.4% effective in preventing mild, moderate, or severe COVID-19. Among clinical trial participants who were over the age of 65, the vaccine was shown to be 78.6% effective in preventing mild, moderate, or severe COVID-19. While these are promising results, this clinical trial was conducted prior to the Delta and Omicron variants becoming predominant. Accordingly, the effectiveness of this vaccine against newer COVID-19 variants is unknown.

Regarding the safety profile of the Novavax vaccine, the most commonly reported side effects include pain, tenderness, redness, and swelling at the injection site, fatigue, muscle pain, joint pain, nausea, vomiting, and fever. The Novavax vaccine may cause individuals to experience an increased risk for myocarditis and pericarditis following vaccination. As a condition for granting EUA for this vaccine, the FDA is requiring Novavax to participate in the Vaccine Adverse Event Reporting System (VAERS), which collects data on adverse events that occur following vaccine administration.

Pandemic Patients recommends consulting with your health care provider to discuss getting vaccinated against COVID-19 as soon as possible. Our Vaccine Eligibility Guide has been updated with the most up-to-date information about the available COVID-19 vaccines, which can be accessed here.  

Additional information about the Novavax COVID-19 vaccine can be accessed here.

FDA Authorizes Pfizer and Moderna COVID-19 Vaccines for Children

On June 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUA) for the Pfizer and Moderna vaccines (marketed as Comirnaty and Spikevax) to allow children as young as six months to get vaccinated against COVID-19. In making this decision, the FDA concluded that the vaccines are safe and effective for use in this population and that the benefits of vaccination outweigh the potential risks.

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FDA Authorizes First Vaccine Booster for Children 5-11

On May 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) to authorize the use of a single booster dose for children between the ages of five and eleven. The FDA authorized the administration of this booster at least five months after the completion of the primary vaccination series with the same vaccine.

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